EUCTR2010-023510-32-BE
Active, not recruiting
Phase 1
A phase IV, randomised, double-blinded, placebo-controlled, parallel study to estimate the influence of vitamin D (D-CURE®) supplementation on the 25-hydroxyvitamin D serum concentration in patients aged over 50 years.
aboratoires SMB S.A.0 sitesDecember 1, 2010
ConditionsPatients are over 50 years old and do not present any significant medical conditions.MedDRA version: 12.1Level: LLTClassification code 10047626Term: Vitamin D deficiency
DrugsD-CURE®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients are over 50 years old and do not present any significant medical conditions.
- Sponsor
- aboratoires SMB S.A.
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female over 50 years old (50 years inclusive);
- •Presenting a Body mass Index between 18 and 35 kg/m² inclusive;
- •Able to comply with all study procedures;
- •Provide written, informed consent to participate in the study, indicated by a personal signature and date on the patient consent form;
- •If the patient is female and of childbearing potential, she must be using an efficient means of birth control, as determined by the investigator and provide a negative blood pregnancy test at the screening visit.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Evidence of any unstable or untreated clinically significant immunological, neoplastic, endocrine, haematological, hepatic, renal, gastrointestinal, neurological or psychiatric abnormalities or medical disease;
- •Patients presenting a thyroid gland dysfunction;
- •UV light solarium use 2 weeks before the screening visit;
- •Use of drugs which may interfere with vitamin D metabolism e.g Phenobarbital, Phenytoin, glucocorticoids;
- •Past or current history of granulomatosis (Besnier\-Boek\-Schaumann disease), Sarcoïdosis, urinary lithiasis, renal insufficiency, cardiac disease, cancer, osteomalacia;
- •Patients who present a vitamin D concentration \> 60 ng/ml at screening;
- •Patients who have a serum creatinine \> 150 µmol/L at screening;
- •Patients who have an albumin corrected serum calcium \> 2\.65 mmol/L (corresponding to 10\.6 mg/dl) at screening;
- •Use of any of the prohibited medication as detailed in the concomitant medication section;
- •Participation in any other clinical trial within 2 months of the screening visit;
Outcomes
Primary Outcomes
Not specified
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